Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:42 AM
Ignite Modification Date:
2025-12-25 @ 1:42 AM
NCT ID:
NCT06691594
Eligibility Criteria:
Inclusion Criteria
Signed written informed consent prior to enrollment
Age ≥ 18 years
ECOG PS score 0-1
Newly diagnosed T1c N1-2 or T2-3 N0-2 breast cancer
Triple-negative breast cancer with PD-L1 CPS \< 10
Hemoglobin ≥ 10.0 g/dl, neutrophils ≥ 1.5 × 10⁹/L, platelet count ≥ 100 × 10⁹/L
BUN ≤ 1.5 × upper limit of normal (ULN), creatinine ≤ 1.5 × ULN
Serum bilirubin ≤ 1.5 × ULN, alkaline phosphatase (AKP), AST, and ALT ≤ 2.5 × ULN
Women of childbearing potential must be willing to use contraception during the study
Negative serum or urine pregnancy test within 7 days prior to treatment
Exclusion Criteria
Occult breast cancer
Bilateral breast cancer
Breast tumor unsuitable for SBRT
Unable to undergo MRI scanning
History of other malignancies that may affect survival
Active autoimmune disease or history of autoimmune disease
Current use of immunosuppressants or systemic steroids (within 2 weeks prior to enrollment)
Known allergy to any component of the investigational drugs
Uncontrolled cardiac symptoms or diseases
Active infection or unexplained fever \> 38.5°C during screening/before first dose
Other factors likely to cause early study termination (e.g., serious concurrent illnesses, significant lab abnormalities, or social/family circumstances affecting safety/data collection)
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT06691594
Study Brief:
Protocol Section:
NCT06691594